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99.5% Paclitaxel

(USP26, DMF, Injectable Grade)

 

                                          WARNINGS

Paclitaxel is a cytotoxic anticancer drug, caution should be exercised in handling paclitaxel. The use of gloves is recommended. 

If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, some throat and nausea have been reported.

This product is for pharmaceutical manufacturers and research laboratories use only. It is not for the direct clinical administration.

DESCRIPTION

Paclitaxel is a natural product with antitumor activity. Natural Paclitaxel is extracted from Taxus yunnanensis and purified by HPLC method without any semi-synthesis process.

The chemical name for paclitaxel is (2aR,4S,4aS,6R,9S,11S,12S, 12aR,12bS)-1,2a,3,4,4a,6,9, 10,11,12,12a,12b-Dodecahydro- 4,6,9,11,12,-12b-hexahydroxy- 4a,8,13,13-tetramethyl- 7,11-methano-5H-cyclodeca [3,4]benz[1,2-b]oxet-5-one 6,12b-diacetate,12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3- phenylisoserine.

Paclitaxel is a white to off-white crystalline powder and is highly lipophilic, insoluble in water, and melts at around 216-217C. It has a molecular weight of 853.93 and a molecular formula C47H51NO14 . Paclitaxel has the following structural formula:

SPECIFICATION

Shelf life - 3 years. 

  

Specification 99.5% Paclitaxel (Supplied by 21CEC) Standard (USP26)
Appearance White crystalline powder White crystalline powder     
Identification :           
1. IR Spectrum Conforms Absorption (197K)
2. MASS Spectrum : Conforms   (not required)
3. NMR Spectrum Conforms (not required)
4. UV Spectrum 227 (+/_2) nm. (not required)
5. HPLC retention time      Conforms     Conforms
Specific Optical Rotation         -52.84  -49 ~ -55                       
Melting Point   219.0C               213~ 220C                       
Water                                        0.38% ≤4.0%             
Residue on Ignition                               0.10% ≤0.2%        
Heavy Metal                                      <20ppm ≤20ppm       
Related Compounds:    
1. Baccatin III 0.00% <0.2%
2. 10-Deacetylpaclitaxel 0.00% <0.5%
3. 7-Xylosylpaclitaxel  0.00% <0.2%
4. Cephalomanine (Paclitaxel related compound A) 0.02% <0.5% (a1+a2)*
5. 2",3"-Dihydrocephalomannine
6. 10-Deacetyl-7-epipaclitaxel (Paclitaxel related compound B) 0.05% <0.5%
7. Benzyl analog 0.00% <0.5%(b1+b2)*
8. 3", 4"-Dehydropaclitaxel C
9, 7-Epicephalomannine 0.00% <0.3%
10. 7-Epipaclitaxel  0.03% <0.5%
Any other single impurity Conforms <0.1%
Total Impurities      

 0.38%

≤2.0%  
Organic volatile impurities:    
1.Methanol          11ppm  ≤3000ppm     
2.Acetone        < 10ppm ≤5000ppm      
3.Isopropyl alcohol                               < 10ppm ≤5000ppm     
4.Methylene chloride                                90ppm ≤600ppm     
5.Hexane                                       < 10ppm ≤290ppm         
6.Ethyl acetate         < 10ppm ≤5000ppm    
Bacterial Endotoxins  0.16EU/mg ≤0.4EU/mg    
Microbial Limits      <20cfu/g          ≤100cfu/g 
Total aerobic Microbial <10cfu/g    
Total fungal count <10cfu/g ≤100cfu/g 
Absence of Staphylococcus aureus, Pseudomonas aeruginosa,
Salmonella
 
species, and  Escherichia coli.
Conforms Conforms
Assay (On the anhydrous, solvent- free basis ) 99.87%  97.0 ~ 102.0% 
Conclusion: This product meets the specification of USP26 .

* USP26 requires the sum of a1+a2 is no more than 0.5% .
** USP26 requires the sum of b1+b2 is no more than 0.5%.

        

BACKGROUND AND APPLICATIONS

Nature has provided many excellent medicines to benefit the human health. There are many effective anti-cancer agents in current use originally came from nature.

Paclitaxel may be one of the most important anticancer agents to be developed over the past two decades. Paclitaxel's anti-cancer activity was discovered in the 1960s during a large-scale plant-screening program sponsored by the National Cancer Institute (NCI). 35,000 plant species were screened for anticancer activity.  An extract of the Yew Tree bark was found to have antitumor activity.  That compound was named "Paclitaxel" or "Taxol".

With its unique mechanism of action as an inducer of tubulin assembly, paclitaxel has demonstrated impressive antitumor activity in patients with breast, lung (both non-small cell and small cell), head and neck, and advanced and platinum-refractory ovarian carcinomas.

Today Paclitaxel becomes one of the major chemotherapy agents in cancer treatment.

How Supplied:

  • PACLITAXEL  100 gm

packaged in a double-layer (plastic membrance - aluminum foil) bag and sealed in a aluminum tin .

  • PACLITAXEL   500 gm

Packaged in a double-layer (plastic membrane - alumimum foil) bag and sealed in a alumimum tin.

Storage: Store in original package between 2 and 25C (36 to 77F). Retain in the original tin to protect from light.

Handling and Disposal: Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

References:
1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.

2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 253 (11): 1590-1592.

3. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts, 02115.

4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.

5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. Ca-A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.

6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033-1049.

7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm 1986; 43:1193-1204.

8. Shi QW, Oritani T, Sugiyama T. Three novel bicyclic taxane diterpenoids
with verticillene skeleton from the needles of Chinese yew, Taxus chinensis var. mairei. Planta Med 1999 May;65(4):356-9

9. Shi QW, Oritani T, Sugiyama T. Kiyota H.   Three novel bicyclic 3,8-secotaxane diterpenoids from the needles of the chinese yew, taxus chinensis var. mairei. J Nat Prod 1998 Nov;61(11):1437-40

10. Shi QW, Oritani T, Sugiyama T. Two bicyclic taxane diterpenoids from the needles of taxus mairei. Phytochemistry 1999 Feb;50(4):633-6

11. Shi QW, Oritani T, Sugiyama T, Yamada T. Isolation and structural determination of a novel bicyclic taxane diterpene from needles of the Chinese yew, Taxus mairei. Biosci Biotechnol Biochem 1999 Apr;63(4):756-9

12. Liang J, Kingston DG. Two new taxane diterpenoids from Taxus mairei. J Nat Prod 1993 Apr;56(4):594-9

13. Shen YC, Tai HR, Chen CY. New taxane diterpenoids from the roots of Taxus mairei. J Nat Prod 1996 Feb;59(2):173-6

14. Shen YC, Chen CY. Taxane diterpenes from Taxus mairei. Planta Med 1997 Dec;63(6):569-70

15. Ma W, Stahlhut RW, Adams TL, Park GL, Evans WA, Blumenthal SG, Gomez GA, Nieder MH, Hylands PJ. Yunnanxane and its homologous esters from cell cultures of Taxus chinensis var. mairei. J Nat Prod 1994 Sep;57(9):1320-4

16. Min ZD, Jiang H, Liang JY. Studies on the taxane diterpenes of the heartwood from Taxus mairei. Yao Hsueh Hsueh Pao 1989;24(9):673-7

17. Shen YC, Chen CY, Kuo YH. A new taxane diterpenoid from Taxus mairei. J Nat Prod 1998 Jun 26;61(6):838-40

18. Fukushima M, Takeda J, Fukamiya N, Okano M, Tagahara K, Zhang SX, Zhang DC, Lee KH.   A new taxoid, 19-acetoxytaxagifine, from Taxus chinensis. J Nat Prod 1999 Jan;62(1):140-2

19. Chen WM, Zhang PL, Wu B, Zheng QT.
Studies on the chemical constituents of Taxus yunnanensis. Yao Hsueh Hsueh Pao 1991;26(10):747-54
20, Zhang S, Chen WM, Chen YH. Isolation and identification of two new taxane diterpenes from Taxus chinensis (Pilger)Rehd. Yao Hsueh Hsueh Pao 1992;27(4):268-72

21. Zhang S, Tung-Ling Lee C,
Kashiwada Y, Chen K, Zhang DC, Lee KH, Yunantaxusin A, a new 11(15-->1)-abeo-taxane from Taxus yunnanensis. J Nat Prod 1994 Nov;57(11):1580-3

22. Chen YJ, Chen CY, Shen YC, New taxoids from the seeds of taxus chinensis. J Nat Prod 1999 Jan;62(1):149-51

23. Liang JY, Min ZD, Iinuma M, Tanaka T, Mizuno M, Two new antineoplastic diterpenes from Taxus mairei. Chem Pharm Bull (Tokyo) 1987 Jun;35(6):2613-4

24. Srinivasan V, Ciddi V, Bringi V
Shuler ML, Metabolic inhibitors, elicitors, and precursors as tools for probing yield limitation in taxane production by Taxus chinensis cell cultures. Biotechnol Prog 1996 Jul-Aug;12(4):457-65

25. Fan J, Tang g, Shu G, Xu X, On the conservation and regeneration of Taxus resources. Chung Kuo Chung Yao Tsa Chih
1996 Jul;21(7):389-91, 446

 

 


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